Will Neurim decision lead to more SPC applications or more CJEU references?

This article was first published in Intellectual Property Magazine 1 Sept 12.

In the July issue of Intellectual Property Magazine, we reported on the Advocate General's Opinion in the Neurim SPC case (1). The Court of Justice of the European Union (CJEU) has now delivered its decision and although its answers to the questions referred are essentially the same, it is unclear to what extent, if any, the reasoning differs from that of the AG.

The CJEU has confirmed that it is possible to obtain a supplementary protection certificate (SPC) for a new patented use of a known product where such product was previously covered by a marketing authorisation (MA) for a different use. This is a significant decision with potentially wide commercial ramifications especially as a number of patent offices across the European Union had up until now refused SPCs for second or further medical uses.

In the present case, the relevant product is melatonin, a natural hormone discovered in 1958 previously authorised for veterinary use. Neurim developed CIRCADIN, a pharmaceutical formulation of melatonin to treat insomnia. When Neurim eventually applied for an SPC relying on its CIRCADIN MA which was granted more than 15 years after the basic patent was filed, the UK IPO rejected the application on the grounds that, contrary to Article 3(d) of the SPC Regulation (2), Neurim’s MA was not the first MA relating to melatonin (the first being REGULIN for veterinary use).

The High Court of Justice agreed with the UK IPO. On appeal to the Court of Appeal, the Court expressed strong sympathy with Neurim's predicament and decided to refer a number of questions to the CJEU.

The CJEU has concluded that the mere existence of an earlier MA ("MA I") obtained for a veterinary medicinal product does not preclude the grant of an SPC under Article 3 for a different application of the same product for which an MA ("MA II") has also been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC. In interpreting Article 13(1), the first MA is the MA within the limits of the protection conferred by the basic patent within the meaning of Article 4.

The CJEU has further held that neither the fact that MA II may require a full regulatory application (3) nor that the product covered by MA I is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant affects the above conclusions.

Whilst the CJEU's conclusions mirror that of the AG, the CJEU makes no direct reference to the AG's analysis and conclusions, which are only advisory in nature and do no bind the CJEU. Thus it cannot be assumed that the CJEU adopted the same reasoning as the AG.

Having said that, even though the CJEU does not expressly confirm a teleological interpretation of the SPC Regulation, such an approach is supported by the CJEU's reference in the decision to the fundamental objective of the SPC Regulation being "to ensure sufficient protection to encourage pharmaceutical research" and that "the reason given for the adoption of the SPC Regulation is the fact that the period of effective protection under the patent is insufficient to cover the investment put into pharmaceutical research".

It is unlikely that the Neurim decision will be limited to the specific facts of the case. Indeed, the decision considers scenarios where the earlier MA is for human use indicating that the principle would apply in relation to further human medical uses and applications. At least these are arguments that we expect the pharmaceutical industry to use in future SPC applications.

Melatonin was never protected by a product patent nor was an SPC grated relating to the first MA for melatonin. Nonetheless we expect the pharmaceutical industry to push for a broad interpretation of the Neurim decision, such that it should be possible to obtain an SPC for a formulation patent or a further use patent where the product that is the subject of the SPC has been claimed in a prior patent. Further, they are likely to argue that the fact that an SPC may have been granted in relation to the product claimed in the prior patent should not preclude the grant of an SPC on the basis of the latter patent as long as latter SPC application "is within the limits of the protection conferred by the basic patent relied upon". This is despite the condition in Article 3(c) that "the product has not already been the subject of a certificate".

Pharmaceutical companies will be actively reviewing their patent filing strategy with a view to eventual increased numbers of SPC applications based on further medical uses or applications. We will have to wait and see whether patent offices and national courts will apply the Neurim decision broadly but, if they do, the generics industry is unlikely to sit idly by. Yet again, this decision leads to unanswered questions likely to result in further references to the CJEU.

Mark Hodgson is a partner in the IP&TechnologyDispute Resolution Group at Field Fisher Waterhouse LLP. He specialises in patent litigation before the UK courts and courts in Europe particularly on behalf of life science companies.